MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001); Pneumonia (2011)

Event Date 07/13/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube and percutaneous endoscopic jejunal tube (j-tube).On (b)(6) 2023, the patent reported that the peg-j tube had caught on a door knob and j tube pulled out 30cm.On (b)(6) 2023 the patient was seen in the gi clinic where the j tube was reinserted.Additional information received on 21 jul 2023 indicated that the patient went to the hospital on (b)(6) 2023 due to pain all over.The patient was diagnosed with a perforated stomach described as a ¿tear/hole in the stomach.¿ the patient decided preoperatively to remove the tubing and discontinue duodopa therapy.On (b)(6) 2023, the patient underwent an unspecified surgical procedure to repair the tear in the stomach.The tubing was removed and duodopa therapy was discontinued.On an unknown date postoperatively, the patient experienced pneumonia and was transferred to the icu department.It was reported that the patient was in icu for 7 days and had improved with an anticipation of a regular room transfer.Additional information received from a nurse on 30 aug 2023 who reported that the patient passed away on (b)(6) 2023 with unknown cause of death.It was unknown if an autopsy was performed.The patient did not have duodopa tubing for approximately 4 weeks before passing away.No further information was available.Multiple attempts have been made to obtain additional information without success.This event has been reported conservatively.

Manufacturer Narrative

Reference record (b)(4).It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.Gastric perforation and pneumonia are known complication of a peg tube/ j-tube placement.Multiple attempts have been made to obtain additional information without success.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 17807920
• MDR Text Key: 324141054
• Report Number: 3010757606-2023-00653
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBVIE J TUBE, UNKNOWN LOT #
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female